Prosthetic valves are utilized to replace malformed, damaged, diseased or otherwise malfunctioning valves in body passageways, such as heart valves including the tricuspid valve, mitral valves the aortic valve and the pulmonary valve. Such prosthetic heart valves are typically implanted into the heart either by open chest surgery, which requires a sternotomy, or by minimally invasive surgery, which requires a thoracotomy between adjacent ribs.
Heart valve prosthesis may be divided into two groups, namely tissue valves and mechanical valves. Typically, bioprosthetic tissue valves are harvested from a suitable animal, usually a porcine heart, prepared according to known methods, and may be mounted to a stent to facilitate implantation. Tissue valves prepared from pericardial tissue are also known in the art. Mechanical valves, by contrast, utilize synthetic materials to form a valve having a ball, a disk, a pair of leaflets (bileaflet), or a plurality of leaflets to regulate blood flow therethrough.
A number of packaging designs have been developed for holding and transporting tissue heart valve bioprostheses. One such design provides a tissue valve holder which suspends the tissue valve in a container having a storage solution. The tissue valve remains suspended in the solution and sealed within the container until the valve is removed by the surgeon for implantation into a patient.
An example of such a packaging design is disclosed in U.S. Pat. No. 5,560,487 to Starr. The packaging system disclosed in Starr utilizes a holder that suspends the tissue valve in a container of preservative. However, the holder is not able to suspend the tissue valve once removed from the container. In the case of a valved conduit, the holder disclosed in Starr does not maintain the shape of the tissue valve because only three points of contact are used to secure the aortic root of the valve to the holder.
Maintaining the tissue valve in suspension after removal from the container is desirable to prevent the valve from coming into contact with other surfaces which may not be sterile. Maintaining the shape of the valve in the container is desirable to avoid deforming or damaging the valve during shipping and handling. As such, an improved holder for holding a tissue valve is desirable.